A study to test the effectiveness and safety of test product BIIB092 compared to placebo in participants with progressive supranuclear palsy, arare and progressive condition that can cause problems with balance, movement, vision, speech and swallowing

Phase 1

• Conditions: Progressive supranuclear palsy; MedDRA version: 21.1Level: PTClassification code 10036813Term: Progressive supranuclear palsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002554-21-IT
• Lead Sponsor: BIOGEN IDEC RESEARCH LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-02-07
• Study Start: 2021-05-25
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

-Participants with probable or possible PSP
-Able to ambulate independently or with assistance
-Able to tolerate MRI
-Have reliable caregiver to accompany participant to all study visits
-Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at
screening
-Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 321

Exclusion Criteria

-Presence of other significant neurological or psychiatric disorders
-Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neauron disease
-History of early, prominent rapid eye movement (REM) sleep behaviour disorder
-History of or screening brain MRI scan indicative of significant abnormality
-Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified